Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoyal College of Surgeons, Ireland

About this trial

Urinary incontinence is a common complication following radical prostatectomy and can significantly impact quality of life. Pelvic floor physiotherapy is recommended to reduce post-operative incontinence; however, referral pathways and patient engagement vary.

The PRO-ACT trial is a single-centre, parallel-group randomised controlled trial evaluating whether a structured pre-operative education bundle combined with direct physiotherapy referral reduces urinary incontinence following radical prostatectomy compared to standard care.

Eligible men undergoing radical prostatectomy at Beaumont Hospital will be randomised 1:1 to either:

Standard of care (educational video and recommendation for physiotherapy with patient-initiated referral), or

A structured pre-operative intervention including a one-to-one ANP-led education session, scheduled post-operative follow-up call, and direct referral to supervised pelvic floor physiotherapy.

The primary outcome is mean urinary pad usage per 24 hours at 3 months post-operatively. Secondary outcomes include time to continence, quality of life, physiotherapy adherence, and postoperative complication rates.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Pre-Operative Education and Physiotherapy Recommendation

    Other intervention

    Provision of educational video material and verbal recommendation for pelvic floor physiotherapy. Referral is patient-initiated, and no scheduled follow-up telephone support is provided.

  • Pre-Operative Nurse-Led Education with Direct Physiotherapy Referral

    Behavioral

    One-to-one pre-operative education session delivered by an Advanced Nurse Practitioner, scheduled follow-up telephone call 7-10 days post-operatively, and direct referral to supervised pelvic floor physiotherapy.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Standard Care PathwayActive comparator 1 intervention
Group B: PRO-ACT Intervention BundleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean Number of Urinary Pads Used Per 24 Hours

Mean number of urinary pads used per 24-hour period at 3 months following radical prostatectomy, recorded using a 7-day pad diary completed by participants.

Time frame
3 months post-operatively

Secondary outcomes

1

Mean Number of Urinary Pads Used Per 24 Hours at 6 Weeks

Mean number of urinary pads used per 24-hour period at 6 weeks following surgery, recorded using a 7-day pad diary.

Time frame
6 weeks post-operatively
2

Time to Continence

Time from surgery to achievement of continence, defined as the first 7 consecutive days with zero pad use.

Time frame
Up to 3 months post-operatively

Other outcomes

Sponsors and contacts

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